An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma

NCT00738582 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: MORAb-009-003 Amatuximab2008-005448-18
• Study Type: interventional
• Target: 89
• Locations: 5 countries
• Sites: 28

Brief Summary

This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.

Conditions

Malignant Pleural Mesothelioma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6

  Number of participants with PFS responders and non-responders at Month 6 was reported. PFS was defined as the time from the date of the first dose of amatuximab to the date of disease progression or death due to any cause, as determined by independent radiologist based on the modified Response Evaluation Criteria in Solid Tumors (RECIST) utilizing the total tumor measurement (performed by computerized tomography (CT)/magnetic resonance imaging (MRI)) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement. A "response", in terms of PFS, was defined to be at least a 6-month stabilization of disease. Progressive disease (PD) as measured by Modified RECIST was defined as an increase of at least 20 percent (%) in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.

  Month 6

Secondary Outcomes (5)

• Overall Response Rate (ORR)

  From the date of first dose until evidence of CR or PR, up to approximately 5 years

• Duration of Response (DR)

  From the first documentation of objective response (CR or PR) to the first documentation of disease progression, up to approximately 5 years

• Time to Tumor Response (TTR)

  From the date of the first dose to first documentation of objective response, up to approximately 5 years

• Overall Survival (OS)

  From the date of first dose to the date of death, up to approximately 5 years

• Overall Progression Free Survival

  From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 years

Other Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab

  From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years

Study Arms (1)

Open Label

EXPERIMENTAL

Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)

Drug: MORAb-009 (Amatuximab); Drug: Pemetrexed; Drug: Cisplatin

Interventions

MORAb-009 (Amatuximab) DRUG

MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles.

Open Label

Pemetrexed DRUG

Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles

Open Label

Cisplatin DRUG

Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of malignant pleural mesothelioma (MPM) with the following characteristics: unresectable disease (or otherwise not a candidate for curative surgery); epithelial type or biphasic (mixed) type with low sarcomatous content.
• Measurable disease at Screening by computed tomography (CT)(or magnetic resonance imaging \[MRI\]).
• KPS of greater than or equal to 70% at Screening.
• Life expectancy of at least 3 months

You may not qualify if:

• Sarcomatous type of mesothelioma
• Prior systemic therapy or radiotherapy for MPM; local radiotherapy for symptom control (ie, non-curative intent) is permitted.
• Confirmed presence of CNS tumor involvement.
• Evidence of other active malignancy requiring treatment.

Sponsors & Collaborators

• Morphotek: lead

Study Sites (28)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California, San Diego

La Jolla, California, 92093, United States

Location

UCLA Medical Hematology & Oncology

Los Angeles, California, 90095, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Johns Hopkins University--Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

NIH/National Cancer Institute

Bethesda, Maryland, 20892, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Laval

Quebec, PQ, G1V 3E6, Canada

Location

HELIOS Klinikum Emil von Behring

Berlin, 14165, Germany

Location

Asklepios Fachkliniken Müchen-Gauting

Gauting, 82131, Germany

Location

Krankenhaus Großhansdorf

Großhansdorf, 22927, Germany

Location

Asklepios Klinik Harburg

Hamburg, 21075, Germany

Location

Medizinsche Hochschule Hannover

Hanover, 30625, Germany

Location

Fachklinik für Lungenerkrankungen Immenhausen

Immenhausen, 34376, Germany

Location

Medizinische Klinik (Hämatologie/Onkologie)

München, 81657, Germany

Location

Medisch Spectrum Twente

Enschede, 7513 ER, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

H. de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Consorci Sanitari Parc Taulí

Barcelona, 08208, Spain

Location

H. Son Dureta

Palma de Mallorca, 07014, Spain

Location

Clínica Universitaria de Navarra

Pamplona, 31008, Spain

Location

H. Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

amatuximab; Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai Inc.

esi_oncmedinfo@eisai.com

1-888-274-2378

Study Officials

• Bruce Wallin, MD

  Morphotek

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2008
• First Posted: August 20, 2008
• Study Start: December 31, 2008
• Primary Completion: June 30, 2011
• Study Completion: January 10, 2014
• Last Updated: September 22, 2022
• Results First Posted: September 22, 2022

Record last verified: 2015-11

Locations

ES (5); DE (7); NL (2); CA (2); US (12)